Risk Stratification in Acute Care: The Meaning of suPAR Measurement in Triage

NCT02643459 | Completed Results DMC

• 1 other identifier: HerlevH01
• Study Type: interventional
• Target: 20,000
• Locations: 1 country
• Sites: 1

Brief Summary

Will clinical outcome for patients be improved if triage in Acute wards and Emergency rooms is supplemented with a prognostic biomarker?

Conditions

Triage; Risk Stratification With Biomarker

Keywords

Triage; Risk stratification; Acute care; suPAR

Outcome Measures

Primary Outcomes (1)

• All Cause Mortality

  Time frame starts at the beginning of the index admission, defined as first admission in the study period. Patients will be followed using central registers.

  10 months after the inclusions period ends mortality data will be assessed

Secondary Outcomes (7)

• All Cause Mortality

  1 months after index admission mortality data will assessed

• Number of Discharges From the Emergency Room Within 24 Hours

  24 hours

• Number of Admissions to the Medical Ward

  30 days

• Number of Patients With an Admission to the Intensive Care Unit

  30 days

• Number of Patients With New Cancer Diagnosis in Control vs Intervention Groups

  10 months after inclusion period ends

Study Arms (2)

Conventional

NO INTERVENTION

no suPAR measurement. Standard care.

suPAR

EXPERIMENTAL

suPAR measurement and education of doctors working in the Emergency department in the meaning of low or elevated levels of suPAR. Since suPAR is measured on all patients regardless of disease the investigators cannot define a single intervention. A possible intervention depends on the clinical situation.

Behavioral: suPAR measurement

Interventions

suPAR measurement BEHAVIORAL

The biomarker suPAR will be measured on all patients included in the study. Before the study period the doctors will receive information on suPAR. We want to study if the information provided by suPAR is useful in emergency medicine. Interventions depends on the clinical issue, as suPAR is an unspecific marker of disease. Usually a elevated suPAR level could result in more investigation e.g. diagnostic procedures or follow up, while a low suPAR could result in faster discharge.

suPAR

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients presenting acutely to the Acute ward/Emergency department and have blood samples done which include both Hemoglobin, C reactive protein and Creatinine within 6 hours of registration within the study period. The study is carried out in 2 Hospitals in the Capital of Denmark.

You may not qualify if:

• Patients presenting in Pediatric, Gynecological or Obstetric units. Patients not being examined with blood samples.

Sponsors & Collaborators

• Herlev Hospital: lead

Study Sites (1)

Herlev Hospital, Department of Cardiology

Herlev, 2730, Denmark

Location

Related Publications (4)

• Schultz M, Rasmussen LJH, Hoi-Hansen T, Kjoller E, Jensen BN, Lind MN, Ravn L, Kallemose T, Lange T, Kober L, Rasmussen LS, Eugen-Olsen J, Iversen KK. Early Discharge from the Emergency Department Based on Soluble Urokinase Plasminogen Activator Receptor (suPAR) Levels: A TRIAGE III Substudy. Dis Markers. 2019 May 19;2019:3403549. doi: 10.1155/2019/3403549. eCollection 2019.

  PMID: 31236143 DERIVED

• Schultz M, Rasmussen LJH, Kallemose T, Kjoller E, Lind MN, Ravn L, Lange T, Kober L, Rasmussen LS, Eugen-Olsen J, Iversen K. Availability of suPAR in emergency departments may improve risk stratification: a secondary analysis of the TRIAGE III trial. Scand J Trauma Resusc Emerg Med. 2019 Apr 11;27(1):43. doi: 10.1186/s13049-019-0621-7.

  PMID: 30975178 DERIVED

• Schultz M, Rasmussen LJH, Andersen MH, Stefansson JS, Falkentoft AC, Alstrup M, Sando A, Holle SLK, Meyer J, Tornkvist PBS, Hoi-Hansen T, Kjoller E, Jensen BN, Lind M, Ravn L, Kallemose T, Lange T, Kober L, Rasmussen LS, Eugen-Olsen J, Iversen KK. Use of the prognostic biomarker suPAR in the emergency department improves risk stratification but has no effect on mortality: a cluster-randomized clinical trial (TRIAGE III). Scand J Trauma Resusc Emerg Med. 2018 Aug 28;26(1):69. doi: 10.1186/s13049-018-0539-5.

  PMID: 30153859 DERIVED

• Sando A, Schultz M, Eugen-Olsen J, Rasmussen LS, Kober L, Kjoller E, Jensen BN, Ravn L, Lange T, Iversen K. Introduction of a prognostic biomarker to strengthen risk stratification of acutely admitted patients: rationale and design of the TRIAGE III cluster randomized interventional trial. Scand J Trauma Resusc Emerg Med. 2016 Aug 5;24:100. doi: 10.1186/s13049-016-0290-8.

  PMID: 27491822 DERIVED

Results Point of Contact

• Title: Dr. Martin Schultz
• Organization: Herlev Hospital, Department of Cardiology

martin.schultz@regionh.dk

004538683868

Study Officials

• Kasper K Iversen, MD, DMSci

  Department of Cardiology, Herlev Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, P.h.D student

Study Record Dates

• First Submitted: November 13, 2015
• First Posted: December 31, 2015
• Study Start: January 1, 2016
• Primary Completion: April 6, 2017
• Study Completion: April 6, 2017
• Last Updated: March 9, 2021
• Results First Posted: March 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)